Proclaim DRG Implantable Pulse Generator Model 3664 — Class II medical device recall Z-0024-2018
Terminated recall by St. Jude Medical, Inc., reported 2017-10-25, distributed nationwide. Analysis of the difference between the actual device longevity and the battery indicator status provided by th
| Recall number | Z-0024-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | St. Jude Medical, Inc., Plano, TX, United States |
| Recall initiated | 2017-09-12 |
| Classified | 2017-10-17 |
| Reported by FDA | 2017-10-25 |
| Terminated | 2020-04-16 |
| Distributed | Nationwide (US) |
| Quantity | 1,744 devices |
| Serial numbers | AAP114.1, AAP267.1, AAP380.1, AAT623.1, ABM656.1, ABT952.1, ACD631.1, ACE905.1, ADJ588.1, ADJ614.1, ADJ842.1, ADJ852.1, ADJ855.1, ADJ863.1, ADJ872.1, ADJ910.1, ADK057.1, ADK078.1, ADK116.1, ADK186.1, ADK293.1, ADN214.1, ADN311.1, ADN340.1, ADN347.1 and 475 more |
| Model numbers | 3664 |
Product
Proclaim DRG Implantable Pulse Generator Model 3664
Reason for recall
Analysis of the difference between the actual device longevity and the battery indicator status provided by the Clinician Programmer (CP) or Patient Controller (PC) has revealed errors in the CP or PC longevity estimations that can overestimate or under estimate the battery indicator status in certain situations.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0024-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.